A multinational biotechnology company had identified a compliance gap in their product stability testing area. The company was not adequately, nor efficiently conducting Out Of Trend (OOT) analysis on their ongoing stability studies. According to FDA’s Guidance for Industry, OOT results should be limited and scientifically justified. Additionally, as the company has recently merged with another large biotech company, the processes and methods of conducting OOT analysis needed to be harmonized and standardized. To remedy the situation, the company decided to develop a bespoke Stability Trending Tool that would automate the OOT analysis and then integrate the tool with their LabWare LIMS and ChemLMS legacy systems. However, before going into production, the new software and its interfaces had to be fully validated and the company lacked the expertise to easily accomplish this.
CSols, Inc., the premier laboratory informatics consultancy, was engaged to supplement the customer’s internal validation team. We were tasked to quickly and efficiently understand the new software, provide guidance and direction on the creation of required system documentation, and communicate the validation approach, schedule and needs across the team. As the project progressed, CSols was also engaged to create all the test cases for the new software and its interfaces and manage a variety of off-shore testers. CSols was selected for this engagement based on our LabWare LIMS expertise (we are a LabWare Partner), our domain expertise as well as our regulatory and computer systems validation (CSV) expertise. Moreover, CSols and the company had a long term relationship wherein multiple informatics projects had been completed and delivered successfully.